Laser Treatment of Basal Cell Carcinoma

Sciton

Status: Completed

Conditions: Basal Cell Carcinoma

Treatments: Device: 1064 nm long-pulse Nd:YAG laser

Study type: Interventional

Funder types: Industry

Identifiers

NCT04936932

BCCCIP001

Details and patient eligibility

About

Laser treatment of Basal cell carcinoma

Full description

The purpose of this pilot study is to examine the treatment of superficial basal cell carcinoma (BCC) with laser technology. The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy subjects 18 years of age or older
2. Lesion is biopsy-proven superficial BCC <= 2.0 cm in largest diameter
3. BCC is on trunk or extremities
4. Seeks and is scheduled for treatment of BCC
5. Willing to have photographs taken of the treatment area
6. Ability to understand and the willingness to sign a written informed consent document
7. Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions

Exclusion criteria

1. Subjects with a BCC lesion that requires excision. This would include relatively larger lesions (>2.0 cm in diameter), high risk lesions as defined by American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
2. Pregnancy
3. Subjects unable to follow-up for the full 12-months
4. Subjects not willing to have biopsy taken from the treatment area
5. Subjects with herpes simplex virus infection, impetigo or other disqualifying condition as determined by a dermatologist on the treatment area or effecting healing or outcome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Standard

Active Comparator group

Description:

1064 Long-pulse Nd:YAG laser Fluence: 120 J/cm2 Number of passes: Single Spot size: 2 cm Pulse width: 8-10 msec

Treatment:

Device: 1064 nm long-pulse Nd:YAG laser

Device: 1064 nm long-pulse Nd:YAG laser

Slow

Active Comparator group

Description:

1064 Long-pulse Nd:YAG laser Fluence: 20-30 J/cm2 Number of passes: Multiple Spot size: 2 cm Pulse width: 8-10 msec

Treatment:

Device: 1064 nm long-pulse Nd:YAG laser

Device: 1064 nm long-pulse Nd:YAG laser